Integration of Biorelevant Pediatric Dissolution Methodology into PBPK Modeling to Predict In Vivo Performance and Bioequivalence of Generic Drugs in Pediatric Populations

In this study, CDER researchers looked for potential differences in dissolution profiles based on gastrointestinal (GI) fluid volume, composition, and bile salt concentrations in adult and pediatric patients.
Source: FDA Center for Drug Evaluation and Research - What's New - Category: Drugs & Pharmacology Authors: Source Type: news